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Showing 2761–2780 of 22584 results

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Cobra 3-Plate EMG ET Tube (Neurovision) – Incorrect Tube Size (2024)

mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.

FDAJul 1, 2024Nationwide• Neurovision Medical Products Inc

Everest Bipolar Cutting Forceps (Olympus) – Packaging Breach (2024)

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

FDAJul 1, 2024Nationwide• Olympus Corporation of the Americas

Gore Viabahn VBX Heparin (Gore) – Packaging Defects (2024)

Due to packaging defects, sterility assurance and heparin activity may be compromised.

High

FDAJul 1, 2024Nationwide• W L Gore & Associates, Inc.

IntelliVue Patient Monitor MX400 (Philips) – Software Configuration (2024)

Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,

FDAJun 28, 2024Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX500 (Philips) – Software Configuration (2024)

Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,

FDAJun 28, 2024Nationwide• Philips North America Llc

Baxter PST 500 U Surgical Table (Baxter) – Potential Device Issue (2024)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table. This could potentially result in unintentional patient movement during surgical procedures and/or preparation for surgical procedures, including transport.

FDAJun 28, 2024Nationwide• Baxter Healthcare Corporation

Arctic Sun Temperature System (Medivance) – Temperature Control Issue (2024)

If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.

FDAJun 27, 2024Nationwide• Medivance Inc.

Link SymphoKnee Sizing Template (Link Bio) – Labeling Error (2024)

The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.

FDAJun 27, 2024Nationwide• LINK BIO CORP

Medline Semi-Rigid Suction Liners (Medline) – Adverse Events (2024)

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.

FDAJun 27, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Ventana Anti-CD10 Antibody (Ventana) – Staining Inaccuracy (2024)

Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.

FDAJun 27, 2024Nationwide• Ventana Medical Systems, Inc.

Capio SLIM Suture Device (Boston Scientific) – Capture Inconsistency (2024)

Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

FDAJun 27, 2024Nationwide• Boston Scientific Corporation

Medline Convenience Kits (Medline) – Suction Liner Concern (2024)

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.

FDAJun 27, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Convenience Kits (Medline) – Unspecified Issue (2024)

XXX

FDAJun 27, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

CADD Medication Cassette Reservoir (Smiths Medical) – Weld Joint Weakness (2024)

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

FDAJun 26, 2024Nationwide• Smiths Medical ASD Inc.

ARTIS Angiography System (Siemens) – Detector Potential Issue (2024)

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

FDAJun 26, 2024Nationwide• Siemens AG/Siemens Healthcare GmbH Rittigfeld 1 Forchheim Germany

DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

CADD-Solis Battery Pack (Smiths Medical) – Adapter Damage Risk (2024)

The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

FDAJun 26, 2024Nationwide• Smiths Medical ASD, Inc.

DVOT Multi-Pathogen Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

ENT Reservoir Kit (Smiths Medical) – Weld Joint Weakness (2024)

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

FDAJun 26, 2024Nationwide• Smiths Medical ASD Inc.

BD Insyte Autoguard IV Catheter (BD) – Tubing Hole Risk (2024)

Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

FDAJun 26, 2024IL• Becton Dickinson Infusion Therapy Systems, Inc.

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